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By PharmaCompass
2019-01-10
Impressions: 132 Article
This week, Pfizer announced that two manufacturing sites in India which it had acquired through its US $ 17 billion acquisition of Hospira will cease manufacturing operations. The sites located near Chennai (Irungattukottai) and Aurangabad employ 1,700 people. In the announcement Pfizer said “the exact timing of the exit of the sites is to be determined”.
The Irungattukottai site received an FDA warning letter in 2013 and in 2016, Pfizer halted production at the plant after a PIC/S (short for Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme) joint inspection with regulators from four international agencies, MHRA (Medicines and Healthcare products Regulatory Agency of the UK), USFDA (United States Food and Drug Administration), TGA (Therapeutic Goods Administration of Australia) and Health Canada, found various quality control problems.
A Pfizer spokesperson had then told The Economic Times: “A holistic plan is being developed to address specific inspection observations and to implement enhancements to site operations.”
In the recent announcement, the company said, “that due to the significant long-term loss of product demand, manufacturing at these sites is not viable.”
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